FLUDROXYCORTIDE 4 MICROGRAMS PER SQUARE CENTIMETRE TAPE

Transcript

Package leaflet: Information for the user
®
PACKAGE LEAFLET: INFORMATION FOR THE USER

HAELAN TAPE

Fludroxycortide

Read
all of this leaflet carefully before you start using this medicine
Fludroxycortide
because it contains important information for you.
Read all of this leaflet carefully before you start using this medicine.
- Keep this leaflet. You may need to read it again.
Keep this leaflet. You may need to read it again. If you have any further
-questions,
If you haveask
anyyour
further
questions,
ask your
doctor
or pharmacist.
doctor
or pharmacist.
This
medicine
has been
-prescribed
This medicine
has
been
prescribed
for
you
only.
Do
not
pass it
on toeven if
for you. Do not pass it on to others. It may harm
them,
others.
It may harm
even as
if their
signs
of illness
same gets
as yours.
their symptoms
arethem,
the same
yours.
If any
of the are
sidethe
effects
-serious,
If you get
side
effects,
your doctor
or pharmacist.
This
or any
if you
notice
anytalk
sidetoeffects
not listed
in this leaflet,
please
includes
possible
side effects not listed in this leaflet. See section 4.
tell your any
doctor
or pharmacist.
What is in this leaflet:
In this leaflet:
1.
What Haelan Tape is and what it is used for
1.
What Haelan Tape is and what it is used for
2.
What you need to know before you use Haelan Tape
2.
Before you use Haelan Tape
3.
How to use Haelan Tape
3.
How to use Haelan Tape
4.
Possible side effects
4.
Possible side effects
5.
How to store Haelan Tape
5.
How to store Haelan Tape
6.
Contents of the pack and other information
6.
Further information
1. WHAT HAELAN TAPE IS AND WHAT IT IS USED FOR
1. WHAT HAELAN TAPE IS AND WHAT IT IS USED FOR
Haelan Tape is a thin plastic surgical tape. Each square centimetre contains 4
Haelan Tape is a thin plastic surgical tape. Each square centimetre contains 4
micrograms of the steroid fludroxycortide. The tape is used on difficult to treat
micrograms of the steroid fludroxycortide. The tape is used on difficult to treat
skin conditions, especially when the skin is dry and scaly.
skin conditions, especially when the skin is dry and scaly.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE HAELAN TAPE
2. BEFORE YOU USE HAELAN TAPE
Do not use Haelan Tape
Do not use Haelan Tape for
• for chicken pox
• chicken pox
• for skin reactions to smallpox vaccination
• skin reactions to smallpox vaccination
• for tuberculosis of the skin
• tuberculosis of the skin
• for rosacea of the face
• rosacea of the face
• for acne
• acne
• for dermatitis around the mouth
• dermatitis around the mouth
• for itchiness of the genitals or anus
• itchiness of the genitals or anus
• for skin conditions in babies including eczema or napkin rash
• skin conditions in babies including eczema or napkin rash
• for bacterial skin infections such as impetigo
• bacterial skin infections such as impetigo
• for viral skin infections such as cold sores
• viral skin infections such as cold sores
• for fungal skin infections such as athlete’s foot
• fungal skin infections such as atheletes foot
Do not use Haelan Tape if you are allergic to fludroxycortide or surgical plastic
Do not use Haelan Tape if you are allergic (hypersensitive) to fludroxycortide
tape (listed in section 6).
or to surgical plastic tape.
Warnings and precautions
Take special care with Haelan Tape:
Talk to your doctor or pharmacist before using Haelan Tape.
• If you have ever had an allergic reaction to Haelan Tape (an allergic
• If you have ever had an allergic reaction to Haelan Tape (an allergic reaction
reaction may include a rash, itching, swelling or breathing difficulties) tell
may include a rash, itching, swelling or breathing difficulties) tell your doctor.
your doctor.
• If you have a skin infection or think you have a skin infection tell your
• If you have a skin infection or think you have skin infection tell your
doctor.
doctor.
• If you are using the tape on your face, you should only use the tape for five
• If you are using the tape on your face, you should only use the tape for 5
days.
days.
• Follow your doctor’s instructions.
•Do not use Haelan Tape on children's skin for more than five days and do
Children
not cover it up tightly. This is because children may absorb more steroid
Do medicine
not use Haelan
Tape
on children’s
skinIffor
more
than five
and
do itnot
into their
bodies
than adults.
this
happened
fordays
a long
time
cover
it upstop
tightly.
This
is growing
becauseor
children
may absorb
more steroid medicine
might
them
from
developing
properly.
into• their
bodies
adults.
If this happened for a long time it might stop them
Follow
your than
doctor’s
instructions.
from growing or developing properly.
Taking other medicines
Other
and Haelan
Tape if you are taking or have recently taken
Pleasemedicines
tell your doctor
or pharmacist
Tell
or pharmacist
you are using,
havewithout
recentlya used
or might use
anyyour
otherdoctor
medicines,
includingifmedicines
obtained
prescription.
any other medicines.
Pregnancy and breast-feeding
Pregnancy
and breast-feeding
Do not use Haelan
Tape if you are pregnant, think you could be pregnant, are
Do
not use
if you or
are
pregnant
or breast-feeding,
think you
planning
to Haelan
becomeTape
pregnant
are
breast-feeding.
Ask your doctor
or may
be
pregnantfor
or are
planning
have any
a baby,
ask your doctor or pharmacist for
pharmacist
advice
beforetotaking
medicine.
advice before taking this medicine.
3. HOW TO USE HAELAN TAPE
HOWuse
TOHaelan
USE HAELAN
TAPEas your doctor has told you. You should
3.
Always
Tape exactly
Always
use your
this medicine
as your
doctor
hassure.
told you. Check with your
check with
doctor or exactly
pharmacist
if you
are not
doctor or pharmacist if you are not sure.
Usual doses
Usual
Checkdoses
the label for how to use your medicine and how often to use it. Only put
Check
theonlabel
for how
useskin
your
medicine
how
the tape
the parts
of to
your
your
doctor and
wants
to often
treat. to use it. Only put
the
tape
the parts
ofon
your
skin
your
wants
to treat.
Only
useon
Haelan
Tape
your
skin.
Dodoctor
not put
it in your
mouth
Only
useyour
Haelan
Tape on your skin. Do not put it in your mouth
or over
eyes.
or
over your
Haelan
Tapeeyes.
is easy to use.
Haelan
easy instructions.
to use.
Please Tape
followisthese
Please
follow
these instructions.
Cleaning
the skin

Cleaning
the
skinHaelan Tape, make sure the affected skin is
Before you
apply
Before
youdry.
apply
Haelan
makethe
sure
the
affected
is
clean and
If you
needTape,
to shave
skin
around
theskin
affected
clean
If you
need to
shave
thehow
skinto
around
area, and
yourdry.
doctor
or nurse
will
tell you
do it. the affected
area,
your
doctor
or nurse will
youit how
to do it.you can wash,
Haelan
Tape
is waterproof
so, tell
once
is in place,
Haelan
Tape is or
waterproof
so,Its
once
it is
in place,
you that
can wash,
bathe, shower
even swim.
matt
surface
means
you can
bathe,
shower orover
even
apply make-up
it. swim. Its matt surface means that you can
apply make-up over it.
Cutting the tape
Cutting
the tear
tapeHaelan Tape. Always cut it with clean scissors.
You cannot
You
cannot
tear the
Haelan
Always
it with just
clean
Make
sure that
pieceTape.
you cut
is bigcut
enough
to scissors.
cover the
Make
sure
thatand
theabout
piece 0.5cm
you cutofisunaffected
big enough
justalltoaround.
cover the
affected
area
skin
Your
affected
area
unaffected
all around.
doctor will
telland
youabout
which0.5cm
area tooftreat.
Roundskin
off the
corners Your
of
doctor
will to
tellstop
youitwhich
area
to treat. Round
the corners of the
the patch
curling
or catching
on youroff
clothes.
patch to stop it curling or catching on your clothes.
• Applying Haelan Tape
Once you have removed the paper backing, throw it away and
HT/TP/11v3
apply the adhesive side of the clear tape to your skin. Take care the tape does

CUSTOMER Typharm Ltd
DESCRIPTION Haelan Tape Leaflet
CODE REF. HTTP11v3
PRINTER REF. D55249
Clearly mark on amendments
and return to: proofs@technoprint.net
APPROVED AND PROCEED
AMEND AND RE-SUBMIT
AMEND AND PROCEED
Signature:_________________________
Date:______________________________
Please check all information is correct and
there are no spelling errors. Should errors
or omissions be noticed after printing or
publication, Technoprint regret that they
cannot be held responsible.

• Applying Haelan Tape
Once you have removed the paper backing, throw it away and apply the
adhesive side of the clear tape to your skin. Take care the tape does not stick
to itself as you take off the paper.
The tape will stick better if you stroke the back of it gently from the middle
outwards.
If you need to cover an area of skin which is longer than 7 cm, do not take all
the paper backing off when you cut the tape. Peel back a bit at a time as you
stick the tape onto your skin.
• Haelan Tape is flexible
If the affected area is likely to be moving constantly, for example, because it
is on your hands, fingers, feet, knees or elbows, apply the tape while the skin
is flexed. Segments can be cut from the tape to allow you to mould the tape
into shape over the affected area. If you are applying it to the outer surface of
a knee or elbow, stick it on while the joint is bent. Then you should be able to
bend the joint without disturbing the dressing.
• ‘Awkward’ areas
You may need someone to help you put Haelan Tape on areas which are
difficult to reach.
Your doctor will tell you how long to use the tape for, this is usually 12 hours
per day but can be longer.
Do not use Haelan Tape for long periods of time without speaking to your doctor.
Do not cover the tape with other dressings or tightly fitting clothes.
Some steroids are known to affect certain hormones. If your doctor thinks you
need to be treated for longer periods of time, they may arrange for you to have
hormone tests. If the tape is affecting your hormones, your doctor may tell you
to stop using it. Then your hormones should return to normal.
If you have any further questions on the use of this medicine, ask your doctor
or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not
everybody gets them.
A few patients may have one or more of the following side effects in the area
where they apply Haelan Tape
• Burning, itching, irritated or dry skin.
• Excessive hair growth.
• Acne pimples.
• Pale skin.
• Limp, flabby or thin skin where the tape was.
• Inflammation at the bottom of skin hairs.
• Red spots or lines on the skin.
• Dermatitis around the mouth or contact dermatitis.
• The amount of sugar in your blood and urine may change or your
hormones may be affected, causing weight gain, menstrual irregularities
and hair growth. These effects are rare.
• Skin infections may get worse if they are not treated with an antibiotic or
other medicine.
• Wounds may take longer to heal.
• Children treated with topical steroids have rarely had high fluid pressure in
their skulls. This has caused headaches and swelling.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any
possible side effects not listed in this leaflet. You can also report side effects
directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety
of this medicine.
5. HOW TO STORE HAELAN TAPE
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton
after EXP. The expiry date refers to the last day of that month.
Store in a dry place, below 25°C.
Do not throw away any medicines via wastewater or household waste. Ask
your pharmacist how to throw away medicines you no longer use. These
measures will help protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Haelan Tape contains
- The active substance is fludroxycortide (4 micrograms/cm2).
- The other ingredient is Blenderm surgical tape coated with synthetic adhesive.
What Haelan Tape looks like and contents of the pack
Haelan Tape is a translucent, polythene adhesive film, 7.5cm wide, protected
by a removable paper liner.
It is available as a 20cm, 50cm, or 200cm roll.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Typharm Limited, 14D Wendover Road, Rackheath Industrial Estate,
Norwich, NR13 6LH
Manufacturer:
Packpharm Limited, 14D Wendover Road, Rackheath Industrial Estate,
Norwich, NR13 6LH.
This leaflet was last revised in November 2015.
HT/TP/11v3

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.